Digital Re-print May | June 2013

Kill step validation of low-moisture extrusion

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Innovative extrusion processes without limits. Bhler is the global technology partner for companies producing breakfast cereals, snack foods, or food ingredients on a commercial scale. With its extensive extrusion know-how and its passion for customized solutions, Bhler is always in a position to generate added value and success for any product idea. Bhler offers an integral range of products and services for all process stages from correct raw material handling, cooking and shaping through extrusion to drying of the extruded products. And this for all market segments from breakfast cereals and snack foods to modified flours and starches, texturized proteins, or vitaminized rice. In short: extrusion processes without limits.
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FEATURE

Kill step
validation of low-moisture extrusion
by Will Henry, research & development, Extru-Tech Inc., USA
Figure: 3 E525 extrusion system

n the USA, the Food and Drug Administration has had a zero tolerance policy for Salmonella since 2010, which is why various extrusion industries have experienced a dramatic increase in recalls over the past two years.

In many of these recalls, Salmonella was found in the plant (commonly found in raw materials) and even though very few cases led to sickness, the manufacturer decided to recall all batches produced at that time. Its better to be safe than sorry, but these recalls undermine consumer confidence, damage brands and impact the entire industry. While every manufacturer strives for products that are 100 percent pathogen free, applicable and validated scientific studies to support properly designed extrusion food safety systems werent possibleuntil now.

Kill step validation

To mimic how products are contaminated under real-world production facility conditions, Extru-Tech built a BSL (BioSafety Level) 2 pilot plant outfitted with a

production scale Extru-Tech E525 extrusion system. As a result, Extru-Tech now offers the industrys first scientific validation study of a food/feed extrusion system that kills Salmonella at levels higher than normally found in most facilities. In an effort to target an industry with the highest exposure, Extru-Tech chose to first address specific issues within the pet food industry by tailoring their validation protocol to an adult canine specification. However, due to the equipment design duplicity, this same architecture and protocol provides credibility to multiple extrusion markets. Extru-tech is using actual equipment that you would find in most pet food plants in a bio-hazard laboratory or a pilot plant, says Dr Jim Marsden, regents distinguished professor, Kansas State University. Raw materials can be inoculated with Salmonella or other pathogens and the effect of the extrusion process can be exactly quantified. This process is a breakthrough for the pet food industry.

Key considerations used in the study

For the development stage of this process, key operational parameters were analyzed to scientifically validate a typical extruded pet food process. Equipment scale - production rates Impartial and internal studies have proven the agnostic relationship between laboratory scale equipment and production scale equipment Equipment configuration - barrel screw stack-up, preconditioner paddle configuration Impartial and internal studies have shown that even the slightest change in equipment setup will impact the processs pathogenic efficacy Formulation Impartial and internal studies provide excellent insight into the variations inherent within individual ingredient components and how they interact differently within a processing environment (i.e. thermal energy efficiency, water absorption, energy of gelatinization) Product specification Parameters such as: size, shape, density, cell structure, moisture and water activity Impartial and internal studies reflect that specific changes in product characteristics via process management, equipment configuration or formulation, will directly affect the efficiency of microbiological control.

Production scale vs traditional testing methods

Food/feed manufacturers have relied on traditional lab studies based on testing equipment ranging from beakers and pressure pots to table-top model extruders. Most testing has been completed on a lab table at very low production rates of 30 g to a 1 kg per hour - not exactly real world conditions. Typically for a pilot scale extrusion lab, the Extru-Tech model E325 would be used. However, the smallest change, from the lab E325 (3.25 in

Figure 1: Collection of equipment architecture that represent models for existing validations

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FEATURE

bore) to a production E525 (5.25 in bore), translates to a production rate of 200 to 600 pounds per hour for the E325 and upwards of 8,000 pounds per hour for the E525 (in terms of typical pet food). The process data translation is cumbersome at best and filled with non-linearity. With all this in consideration the BSL-2 pilot plant was outfitted with a E525 production scale extruder system and the equipment was configured for the production of an industry generic low-moisture dry-expanded pet food.

A significant point of discovery is how a raw material is contaminated or inoculated in a factory. Various preemptive trials, discovered that many of the readily available and scientific methods of inoculation are not truly representative of a typical contamination event that our clients deal with on a daily basis. For example, some studies have developed thermal survivability profiles (charts that show death of various microbes against time or temperature). However, these data sets were created with the microbes suspended in a largely aqueous solution. If Salmonella is in a liquid, heat will transfer quickly and kill it quickly. However, this is not a representation of what happens in a pet food plant and creates a false set of operational parameters that do not control Salmonella. For pet food, food, and feed manufacturers, Salmonella is usually introduced through dry ingredients. For this reason, we developed a dry inoculant. A dry inoculant

Figure: 2 E925 high capacity extrusion system (13 to 15 t/hr pet food)

Creating a dry inoculant test

introduced into the ingredient stream better represents how the pathogens are usually present within contaminated raw ingredients. The obvious pathogen choice was a 3-serotype cocktail of Salmonella as it is the most opportunistic organism that is prevalent in the pet food industry and the media. The selected industry generic pet food formula was charged with a tailored inoculant that represents typical contamination events in the manufacturing process. Ultimately all three replications of the challenge study resulted in a log reduction of Salmonella that exceeded the 5-log reduction requirement of a CCP allocation.

Validation 101
As any food safety auditor may tell you, the ability to correlate the assignment of critical control points (CCPs) to scientifically validated proof of their effectiveness in the control of targeted pathogens is ultimate confirmation of effectiveness. All food manufactures are required under the Food Safety Modernization Act (FSMA) to develop written food safety plans, says Dr Marsden. For example, if Salmonella is a hazard that is reasonably likely to occur in the process or product, then a series of interventions are required and they must be scientifically proven. Validation is the process of demonstrating that a food safety system (HACCP, CCPs, CLs) as designed can adequately

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FEATURE

Study parameters
Possible paths for validation of a typical pet food process were reviewed in order of preference and viability: Pilot plant - most accepted and least risk Configure a pilot plant with representative production-scale equipment models and perform a tailored challenge study with specific formulations, equipment configuration, product specifications and targeted pathogens Pros - correlation becomes moot, no risk Cons none In-plant surrogate Select non-pathogenic surrogate and inoculate actual production process flow Pros - matched equipment and process model Cons - lack of applicable (correlation) challenge study data In-plant pathogenic Inoculate actual production process flow with pathogenic microbe Pros - correlation becomes moot. Cons - risk of future events and liability thereof Laboratory validation Secure a BSL-2 laboratory to perform bench-top validation Pros - specific pathogen, surrogate correlation, tailored formulation Cons - does not replicate equipment scale, configuration or the manufacturing process Scientific literature - least accepted and most risk Search for existing scientific data that best represents your manufacturing model Pros - least cost Cons - difficult to find a single study that will be even minimally representative of a pet food extrusion process

Figure 4: Summary data of extrusion validation for all three repetitions

Figure 5: XX Extru-Tech Inc. pilot plant control system screenshot depicting CCP verification

control (5-log reduction) the identified hazards to produce a safe product. As the United States Department of Agriculture indicates there are two distinct elements of validation: The scientific justification or documented basis for the system design requires scientific and technical documentation that demonstrates the designed process can control the identified hazard. The practical and scientific demonstration must prove the system can perform as expected. This consists of keeping records to demonstrate the plan in operation and that the HACCP plan achieves expectations. Conducting multiple repetitions in a real-time processing environment using full- scale production equipment and actual production formulations that have been inoculated with designated high levels of specific (non-man made) microorganisms. The process also must prove that high levels of microorganisms
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are reduced or killed through the lethality conditions of the CCP. The best way to see how effective an intervention is against certain pathogens is to actually inoculate a food product with Salmonella, says Dr Marsden. We then apply that intervention under conditions that ideally replicate a real-world food plant to measure the reductions associated with that treatment. As a result, we know exactly how effective an intervention is in controlling specific pathogens. Basing a food safety system on impractical data is not safe! By selecting a sub-standard food safety model, you forfeit all leverage to mitigate the risk of a food safety event.

eters that are required to deactivate Salmonella in the extrusion process, says Dr Marsden. There are other production steps that follow where Salmonella could re-contaminate the product. Extru-tech is looking at those additional steps to identify interventions that could be applied downstream to prevent recontamination.

Validating your extrusion food safety system

Until now, an extrusion kill step validation has not been available in the food industry. Extru-Tech now offers scientific validation focused on the extruded foods that exceed FSMA requirements. Extru-tech is documenting the param-

More inforMation:
Tel: +1 785 284 4133 Website: www.extru-techinc.com Newsletter: http://eforms.kmpsgroup. com/wattpub/forms/extr_subscribe.htm

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This digital Re-print is part of the May | June 2013 edition of Grain & Feed Milling Technology magazine. Content from the magazine is available to view free-of-charge, both as a full online magazine on our website, and as an archive of individual features on the docstoc website. Please click here to view our other publications on www.docstoc.com.
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